MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FLAT PE HC LINER Ø40/G

Catalog Number	01.32.4052HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31-july-2019: lot 166672: (b)(4) items manufactured and released on 25-nov-2016.Expiration date: 2021-11-10.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event additional implants involved in the event, batch review performed on 31-july-2019.Screws: mpact 01.32.6525 cancellous bone screw, flat head ø 6,5 l 25 (k103721) lot.167232.Lot 167232: (b)(4) items manufactured and released on 05-dec-2016.Expiration date: 2021-11-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Screws: mpact 01.32.6540 cancellous bone screw, flat head ø 6,5 l 40 (k103721) lot.172444.Lot 172444: (b)(4) items manufactured and released on 31-aug-2017.Expiration date: 2022-08-17.No anomalies found related to the problem/ to date, (b)(4) items of the same lot have been already sold with another similar reported event.Cup: mpact 01.32.160dh acetabular shell ø60 two-holes (k132879) lot.161861.Lot 161861: (b)(4) items manufactured and released on 15-sept-2016.Expiration date: 2021-09-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Mpact 01.31.55tp shell screw plug (k103721) lot.175555.Lot 175555: (b)(4) items manufactured and released on 19-jul-2017.Expiration date: 2022-07-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Ball heads: mectacer 01.29.214 biolox delta ceramic ball head 12/14 ø 40 size l + 4 (k112115) lot.162740.Lot 162740: (b)(4) items manufactured and released on 27-jul-2016.Expiration date: 2021-07-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Stem: minimax 01.13.106l cementless anatomical stem left size 6 (k170845) lot.169038; lot 169038: (b)(4) items manufactured and released on 15-may-2017.Expiration date: 2022-05-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Screws: mpact 01.32.6545 cancellous bone screw, flat head ø 6,5 l 45 (k103721) lot.165280.Lot 165280: (b)(4) items manufactured and released on 05-oct-2016.Expiration date: 2021-09-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all hardware and put in an antibiotic spacer 1 year and 8 months after primary.The surgery was completed successfully.

• Brand Name: LINER: MPACT FLAT PE HC LINER Ø40/G
• Common Device Name: FLAT PE HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8924581
• Report Number: 3005180920-2019-00702
• Device Sequence Number: 253422
• Product Code: LZO
• UDI-Device Identifier: 07630030812286
• UDI-Public: 07630030812286
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/10/2021
• Device Catalogue Number: 01.32.4052HCT
• Device Lot Number: 166672
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR